ZHEJIANG GREAT STAR INDUSTRIAL
⚠️ Moderate Risk
FEI: 3012605294 • Jiaxing, Zhejiang • CHINA
FEI Number
3012605294
Location
Jiaxing, Zhejiang
Country
CHINAAddress
D Nongfa, No 11 Qihui Road; Haining, Jiaxing, Zhejiang, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is ZHEJIANG GREAT STAR INDUSTRIAL's FDA import refusal history?
ZHEJIANG GREAT STAR INDUSTRIAL (FEI: 3012605294) has 1 FDA import refusal record(s) in our database, spanning from 1/23/2023 to 1/23/2023.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. ZHEJIANG GREAT STAR INDUSTRIAL's FEI number is 3012605294.
What types of violations has ZHEJIANG GREAT STAR INDUSTRIAL received?
ZHEJIANG GREAT STAR INDUSTRIAL has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about ZHEJIANG GREAT STAR INDUSTRIAL come from?
All FDA import refusal data for ZHEJIANG GREAT STAR INDUSTRIAL is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.